title: Phase II study of oral S-1 and cisplatin with concurrent radiotherapy for locally advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  To determine the efficacy and safety of oral S-1 in combination with cisplatin and thoracic radiotherapy in patients with unresectable stage III non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  S-1 (50mg/m(2)) was administered orally twice daily for 14 days, with cisplatin (40 mg/m(2)) on days 1 and 8 of each cycle every 3 weeks, for 2-4 cycles. Thoracic radiation therapy was administered in 2 Gy fractions five times weekly for a total dose of 60 Gy. The primary endpoint was the response rate, and secondary endpoints included progression-free survival, overall survival and safety.
  
  
  RESULTS
  Forty-one patients were enrolled in this study. The objective response rate was 87.8% (98% CI: 77.8-97.8%). The median progression-free survival was 467 days (15.4 months), and the median survival time was 904 days (29.7 months). The overall survival rates at 1- and 2-years were 85.7% and 52.9%, respectively. Hematological toxicities included grade 3/4 neutropenia (17%) and grade 3/4 leukopenia (27%). No grade 3 febrile neutropenia was detected, and grade 3/4 non-hematological toxicities were also mild. A grade 3 gastrointestinal hemorrhage was observed in one patient.
  
  
  CONCLUSIONS
  The combination of oral S-1 plus cisplatin with concurrent radiotherapy is a promising treatment with a high efficacy and lower toxicity in patients with locally advanced NSCLC.
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan. Electronic address: kkaira1970@yahoo.co.jp.
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Kaira
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Tomizawa
authors.forename: Reiko
authors.initials: R
authors.lastname: Yoshino
authors.forename: Akihiro
authors.initials: A
authors.lastname: Yoshii
authors.forename: Masana
authors.initials: M
authors.lastname: Matsuura
authors.forename: Yasuki
authors.initials: Y
authors.lastname: Iwasaki
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Koga
authors.forename: Akihiro
authors.initials: A
authors.lastname: Ono
authors.forename: Masaki
authors.initials: M
authors.lastname: Nishioka
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Kamide
authors.forename: Takeshi
authors.initials: T
authors.lastname: Hisada
authors.forename: Tamotsu
authors.initials: T
authors.lastname: Ishizuka
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Shirai
authors.forename: Takeshi
authors.initials: T
authors.lastname: Ebara
authors.forename: Jun-Ichi
authors.initials: J
authors.lastname: Saitoh
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakano
authors.forename: Noriaki
authors.initials: N
authors.lastname: Sunaga
mesh_terms: D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D059248:Chemoradiotherapy / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000209:etiology; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000209:etiology; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin
keywords: Chemoradiotherapy; Cisplatin; Non-small-cell lung cancer; S-1